CTMG, Inc.

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CTMG’s Adaptive Investigative-Site Management® and Adaptive Clinical Trial Design — Powerful disruptive innovations to accelerate Clinical Trial Completion

CTMG has done what one former Global Vice President from a top ten pharmaceutical company called “impossible!”—we have successfully applied cGMP (current Good Manufacturing Practice)-like systems to Physician Investigative Site operations, re-defining Site performance.

CTMG’s Adaptive Investigative-Site Management® (“AIM”) uses the same principles that underlie Adaptive Clinical Trial (“ACT”) design, but applies them to Investigative Site operational conduct. Both approaches utilize rigorous design-reviewed processes to evaluate possible protocol outcomes. Both adapt these processes in response to early data feedback. Both AIM and ACT have been shown to reduce cost, number of required patients or investigational sites, operational bias, time spent on ineffective protocol paths, and time to complete the clinical trial.

Applying cGMP’s rigorous design-reviewed processes that translate a Sponsor protocol into discrete measurable steps, removes the un-quantifiable risk of non-performance that characterizes 70% of Investigative Sites. AIM accomplishes this by linking completion of protocol steps to real time quality review at the Physician Site, to ensure that each step is completed as intended.